Vacancy expired!
- Designing the clinical development strategy in cooperation with an international team
- Defining the study design and statistical analysis of clinical data in cooperation with the Biometrics team.
- Responsible for site compliance with clinical study protocol and ICH/GCP guidelines
- Preparing clinical study plans that meet product design goals and regulatory requirements
- Third party management (e.g. CRO's)
- Study budget negotiations
- Support clinical feasibility studies
- Data preparation, reviews and presentations
- Advanced degree in a scientific area (Master or PhD preferred) or equivalent experience.
- Junior Level - 2 to 3 years of experience working in Clinical Operations within Diagnostics, Medical Devices or Pharma/Biotech
- Senior Level - 5 to 10 years of experience working in Clinical Operations within Diagnostics, Medical Devices or Pharma/Biotech
- Molecular Diagnostics experience is an asset
- Experience in IVD (clinical) development and validation studies is required
- Previous CRA working experience is preferred
- TMF management/organization experience is desired
- Site Audit preparation and execution experience is desired
- Experience in application of international regulatory and quality guidelines for clinical laboratory methods (ISO, FDA, CLSI,)
- GLP and GMP working knowledge
Vacancy expired!